<outcomemeasures>
<outcomemeasure>
<dispersiontype>
Standard Deviation
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.2-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
0.80
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
8.45
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.2-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
0.78
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
8.55
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.2-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
0.81
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
8.63
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Baseline
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.2-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
0.96
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
7.64
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.2-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
1.06
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
7.20
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.2-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
0.95
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
7.33
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Month 12
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
</textblock>
</measuredescription>
<parametertype>
Mean
</parametertype>
<timeframe>
Baseline, Month 12
</timeframe>
<title>
HbA1c (Glycosylated Haemoglobin) at Month 12
</title>
<unitofmeasure>
percentage (%) of total haemoglobin
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Primary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.2-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.2-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.2-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Standard Deviation
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.3-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
0.80
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
8.45
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.3-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
0.78
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
8.55
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.3-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
0.81
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
8.63
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Baseline
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.3-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
1.13
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
7.11
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.3-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
1.17
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
7.04
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.3-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
1.11
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
7.22
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Month 36
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
</textblock>
</measuredescription>
<parametertype>
Mean
</parametertype>
<timeframe>
Baseline, Month 36
</timeframe>
<title>
HbA1c (Glycosylated Haemoglobin) at Month 36
</title>
<unitofmeasure>
percentage (%) of total haemoglobin
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Primary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.3-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.3-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.3-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Not Applicable
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.4-OutcomeRptGroup.1
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
8.1
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.4-OutcomeRptGroup.2
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
23.9
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.4-OutcomeRptGroup.3
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
17.0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Total participants who achieved target
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.4-OutcomeRptGroup.1
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
78.9
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.4-OutcomeRptGroup.2
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
43.9
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.4-OutcomeRptGroup.3
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
52.5
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Subset who achieved target, n=18, 50, 39
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
Two participant counts are listed. The first is the percentage of total participants who achieved the target (HbA1c below or equal to 6.5%) at Month 12. The second is the percentage of subset of participants who achieved the target and did not have either minor or major hypoglycaemic episode within the four weeks prior to the month 12 exam. Minor hypoglycaemic episode is an episode in which the participant was able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major hypoglycaemic episode is an episode in which the participant was unable to treat her/himself.
</textblock>
</measuredescription>
<parametertype>
Number
</parametertype>
<timeframe>
Month 12
</timeframe>
<title>
Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%
</title>
<unitofmeasure>
percentage of participants
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.4-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.4-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.4-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Not Applicable
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.8-OutcomeRptGroup.1
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
43.2
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.8-OutcomeRptGroup.2
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
44.8
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.8-OutcomeRptGroup.3
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
31.9
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
Percentage of participants who achieved the target (HbA1c below or equal to 6.5%) at Month 36
</textblock>
</measuredescription>
<parametertype>
Number
</parametertype>
<timeframe>
Month 36
</timeframe>
<title>
Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%
</title>
<unitofmeasure>
percentage of participants
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.8-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.8-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.8-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Inter-Quartile Range
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0.0
</dispersionlowerlimit>
<dispersionupperlimit>
6.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
2.0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
3.0
</dispersionlowerlimit>
<dispersionupperlimit>
19.2
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
8.0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
1.0
</dispersionlowerlimit>
<dispersionupperlimit>
11.1
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
5.0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
All participants, Grade 1
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
2.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
2.9
</dispersionlowerlimit>
<dispersionupperlimit>
17.7
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
8.0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
1.0
</dispersionlowerlimit>
<dispersionupperlimit>
9.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
3.9
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
All participants, Grade 2
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
All participants, Grade 3
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
2.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
3.0
</dispersionlowerlimit>
<dispersionupperlimit>
18.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
8.0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
1.0
</dispersionlowerlimit>
<dispersionupperlimit>
9.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
3.9
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
All participants, Grade 2 or 3
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
5.2
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
3.9
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
2.0
</dispersionlowerlimit>
<dispersionupperlimit>
21.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
7.8
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
1.5
</dispersionlowerlimit>
<dispersionupperlimit>
12.8
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
5.4
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Achieved HbA1c target, Grade 1, n=18, 50, 39
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
4.9
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
3.0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
2.0
</dispersionlowerlimit>
<dispersionupperlimit>
20.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
8.0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
1.5
</dispersionlowerlimit>
<dispersionupperlimit>
11.4
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
4.0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Achieved HbA1c target, Grade 2, n=18, 50, 39
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Achieved HbA1c target, Grade 3, n=18, 50, 39
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
4.9
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
3.0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
2.9
</dispersionlowerlimit>
<dispersionupperlimit>
20.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
8.7
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.9-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
1.9
</dispersionlowerlimit>
<dispersionupperlimit>
11.8
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
4.0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Achieved HbA1c target, Grade 2 or 3, n=18, 50, 39
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.
</textblock>
</measuredescription>
<parametertype>
Median
</parametertype>
<timeframe>
Month 12
</timeframe>
<title>
Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
</title>
<unitofmeasure>
hypoglycaemic events/participant/year
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.9-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.9-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.9-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Inter-Quartile Range
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
2.3
</dispersionlowerlimit>
<dispersionupperlimit>
3.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
2.7
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
4.3
</dispersionlowerlimit>
<dispersionupperlimit>
7.2
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
5.7
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
3.3
</dispersionlowerlimit>
<dispersionupperlimit>
4.3
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
3.8
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
All participants, Grade 1
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
1.3
</dispersionlowerlimit>
<dispersionupperlimit>
2.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
1.7
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
4.3
</dispersionlowerlimit>
<dispersionupperlimit>
6.9
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
5.5
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
2.3
</dispersionlowerlimit>
<dispersionupperlimit>
4.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
3.0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
All participants, Grade 2
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
All participants, Grade 3
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
1.3
</dispersionlowerlimit>
<dispersionupperlimit>
2.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
1.7
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
4.3
</dispersionlowerlimit>
<dispersionupperlimit>
7.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
5.7
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
2.3
</dispersionlowerlimit>
<dispersionupperlimit>
4.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
3.0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
All participants, Grade 2 or 3
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
1.7
</dispersionlowerlimit>
<dispersionupperlimit>
3.7
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
3.0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
3.5
</dispersionlowerlimit>
<dispersionupperlimit>
7.7
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
5.7
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
1.7
</dispersionlowerlimit>
<dispersionupperlimit>
3.9
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
3.0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Achieved HbA1c target, Grade 1, n=73, 70, 55
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
1.3
</dispersionlowerlimit>
<dispersionupperlimit>
2.7
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
2.0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
3.8
</dispersionlowerlimit>
<dispersionupperlimit>
8.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
5.3
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
1.7
</dispersionlowerlimit>
<dispersionupperlimit>
5.2
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
2.7
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Achieved HbA1c target, Grade 2, n=73, 70, 55
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
0
</dispersionlowerlimit>
<dispersionupperlimit>
0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Achieved HbA1c target, Grade 3, n=73, 70, 55
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
1.3
</dispersionlowerlimit>
<dispersionupperlimit>
2.7
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
2.0
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
4.0
</dispersionlowerlimit>
<dispersionupperlimit>
8.0
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
5.5
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.11-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
1.7
</dispersionlowerlimit>
<dispersionupperlimit>
5.3
</dispersionupperlimit>
<nacomment>
</nacomment>
<parametervalue>
3.0
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Achieved HbA1c target, Grade 2 or 3, n=73, 70, 55
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.
</textblock>
</measuredescription>
<parametertype>
Median
</parametertype>
<timeframe>
Month 36
</timeframe>
<title>
Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
</title>
<unitofmeasure>
hypoglycaemic events/participant/year
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.11-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.11-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.11-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Not Applicable
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.12-OutcomeRptGroup.1
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
17.9
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.12-OutcomeRptGroup.2
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
4.2
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.12-OutcomeRptGroup.3
</reportinggroupid>
<nacomment>
</nacomment>
<parametervalue>
8.9
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.
</textblock>
</measuredescription>
<parametertype>
Number
</parametertype>
<timeframe>
Month 12
</timeframe>
<title>
Percentage of Participants Who Required A Second Insulin Therapy by Month 12
</title>
<unitofmeasure>
percentage of participants
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.12-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.12-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.12-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Not Applicable
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.13-OutcomeRptGroup.1
</reportinggroupid>
<parametervalue>
89
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.13-OutcomeRptGroup.2
</reportinggroupid>
<parametervalue>
82
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.13-OutcomeRptGroup.3
</reportinggroupid>
<parametervalue>
88
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.
</textblock>
</measuredescription>
<parametertype>
Number
</parametertype>
<timeframe>
Month 36
</timeframe>
<title>
Percentage of Participants Who Required A Second Insulin Therapy by Month 36
</title>
<unitofmeasure>
percentage of participants
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.13-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.13-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.13-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Standard Deviation
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.14-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
4.2
</dispersionspread>
<parametervalue>
1.9
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.14-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
4.6
</dispersionspread>
<parametervalue>
5.7
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.14-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
4.0
</dispersionspread>
<parametervalue>
4.7
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
</title>
</measurecategory>
</measurecategories>
<measuredescription>
</measuredescription>
<parametertype>
Mean
</parametertype>
<timeframe>
Week 0 (baseline), month 12
</timeframe>
<title>
Change From Baseline in Body Weight at Month 12
</title>
<unitofmeasure>
kilogram
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.14-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.14-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.14-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Standard Deviation
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.16-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
0.5
</dispersionspread>
<parametervalue>
3.6
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.16-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
0.5
</dispersionspread>
<parametervalue>
6.4
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.16-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
0.5
</dispersionspread>
<parametervalue>
5.7
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
</title>
</measurecategory>
</measurecategories>
<measuredescription>
</measuredescription>
<parametertype>
Mean
</parametertype>
<timeframe>
Week 0 (baseline), month 36
</timeframe>
<title>
Change From Baseline in Body Weight at Month 36
</title>
<unitofmeasure>
kilograms
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.16-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.16-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.16-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Standard Deviation
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
43
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-43
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
43
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-65
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
54
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-59
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
All timepoints excluding 3am
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
52
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-59
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
49
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-23
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
56
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-45
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Fasting
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
54
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-47
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
54
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-83
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
63
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-68
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Postprandial
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
70
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-40
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
59
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-34
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.17-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
70
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-52
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
3am
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.
</textblock>
</measuredescription>
<parametertype>
Mean
</parametertype>
<timeframe>
Baseline, month 12
</timeframe>
<title>
Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months
</title>
<unitofmeasure>
mg/dL
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.17-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.17-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.17-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Standard Deviation
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
43
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-58
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
47
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-67
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
47
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-56
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
All timepoints excluding 3am
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
49
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-47
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
45
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-49
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
47
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-50
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Fasting
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
50
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-67
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
59
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-85
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
58
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-61
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
Postprandial
</title>
</measurecategory>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.1
</reportinggroupid>
<dispersionspread>
77
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-45
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.2
</reportinggroupid>
<dispersionspread>
70
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-27
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.18-OutcomeRptGroup.3
</reportinggroupid>
<dispersionspread>
77
</dispersionspread>
<nacomment>
</nacomment>
<parametervalue>
-38
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
3am
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.
</textblock>
</measuredescription>
<parametertype>
Mean
</parametertype>
<timeframe>
Baseline, month 36
</timeframe>
<title>
Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months
</title>
<unitofmeasure>
mg/dL
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.18-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.18-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.18-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
95% Confidence Interval
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.19-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0.75
</dispersionlowerlimit>
<dispersionupperlimit>
0.81
</dispersionupperlimit>
<parametervalue>
0.78
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.19-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
0.73
</dispersionlowerlimit>
<dispersionupperlimit>
0.79
</dispersionupperlimit>
<parametervalue>
0.76
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.19-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
0.73
</dispersionlowerlimit>
<dispersionupperlimit>
0.80
</dispersionupperlimit>
<parametervalue>
0.76
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.
</textblock>
</measuredescription>
<parametertype>
Mean
</parametertype>
<timeframe>
Month 12
</timeframe>
<title>
Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months
</title>
<unitofmeasure>
units on a scale
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.19-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.19-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.19-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
95% Confidence Interval
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.20-OutcomeRptGroup.1
</reportinggroupid>
<dispersionlowerlimit>
0.77
</dispersionlowerlimit>
<dispersionupperlimit>
0.83
</dispersionupperlimit>
<parametervalue>
0.80
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.20-OutcomeRptGroup.2
</reportinggroupid>
<dispersionlowerlimit>
0.73
</dispersionlowerlimit>
<dispersionupperlimit>
0.81
</dispersionupperlimit>
<parametervalue>
0.77
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.20-OutcomeRptGroup.3
</reportinggroupid>
<dispersionlowerlimit>
0.71
</dispersionlowerlimit>
<dispersionupperlimit>
0.80
</dispersionupperlimit>
<parametervalue>
0.76
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
</title>
</measurecategory>
</measurecategories>
<measuredescription>
<textblock>
The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.
</textblock>
</measuredescription>
<parametertype>
Mean
</parametertype>
<timeframe>
Month 36
</timeframe>
<title>
Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months
</title>
<unitofmeasure>
units on a scale
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.20-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.20-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.20-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
<numunitsanalyzed>
</numunitsanalyzed>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
<typeunitsanalyzed>
</typeunitsanalyzed>
</outcomemeasure>
<outcomemeasure>
<dispersiontype>
Not Applicable
</dispersiontype>
<measurecategories>
<measurecategory>
<reportedvalues>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.21-OutcomeRptGroup.1
</reportinggroupid>
<parametervalue>
227
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.21-OutcomeRptGroup.2
</reportinggroupid>
<parametervalue>
235
</parametervalue>
</reportedvalue>
<reportedvalue>
<reportinggroupid>
OutcomeMeasure.21-OutcomeRptGroup.3
</reportinggroupid>
<parametervalue>
228
</parametervalue>
</reportedvalue>
</reportedvalues>
<title>
</title>
</measurecategory>
</measurecategories>
<measuredescription>
</measuredescription>
<parametertype>
Number
</parametertype>
<timeframe>
Up to month 37 (36 months of treatment plus 1 month follow-up)
</timeframe>
<title>
Number of Participants Having an 'Other' Adverse Event
</title>
<unitofmeasure>
participants
</unitofmeasure>
<anticipatedresultpostingdate>
<month>
</month>
<year>
</year>
</anticipatedresultpostingdate>
<measuretype>
Secondary
</measuretype>
<outcomemeasureanalyses>
</outcomemeasureanalyses>
<outcomereportinggroups>
<outcomereportinggroup
id="OutcomeMeasure.21-OutcomeRptGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
234
</subjectsanalyzed>
<title>
Insulin Detemir (Basal Insulin)
</title>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.21-OutcomeRptGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
239
</subjectsanalyzed>
<title>
Insulin Aspart (Prandial Insulin)
</title>
</outcomereportinggroup>
<outcomereportinggroup
id="OutcomeMeasure.21-OutcomeRptGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<subjectsanalyzed>
235
</subjectsanalyzed>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
</outcomereportinggroup>
</outcomereportinggroups>
<populationanalysisdescription>
<textblock>
Safety population consisting of all randomised participants exposed to at least one dose of trial drug(s).
</textblock>
</populationanalysisdescription>
<reportingstatus>
Posted
</reportingstatus>
<safetyissue>
No
</safetyissue>
</outcomemeasure>
</outcomemeasures>
<participantflow>
<participantflowgroups>
<flowgroup
id="ParticipantFlow-ParticipantFlowGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<title>
Insulin Detemir (Basal Insulin)
</title>
</flowgroup>
<flowgroup
id="ParticipantFlow-ParticipantFlowGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<title>
Insulin Aspart (Prandial Insulin)
</title>
</flowgroup>
<flowgroup
id="ParticipantFlow-ParticipantFlowGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
</flowgroup>
</participantflowgroups>
<periods>
<period>
<completedmilestone>
<milestoneachievements>
<milestoneachievement>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.1
</reportinggroupid>
<subjectsachieve>
189
</subjectsachieve>
</milestoneachievement>
<milestoneachievement>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.2
</reportinggroupid>
<subjectsachieve>
188
</subjectsachieve>
</milestoneachievement>
<milestoneachievement>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.3
</reportinggroupid>
<subjectsachieve>
201
</subjectsachieve>
</milestoneachievement>
</milestoneachievements>
</completedmilestone>
<dropwithdrawreasons>
<dropwithdrawreason>
<dropwithdrawreasondetails>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.1
</reportinggroupid>
<subjectsaffected>
9
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.2
</reportinggroupid>
<subjectsaffected>
0
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.3
</reportinggroupid>
<subjectsaffected>
5
</subjectsaffected>
</reasondetail>
</dropwithdrawreasondetails>
<reasontype>
Adverse Event
</reasontype>
</dropwithdrawreason>
<dropwithdrawreason>
<dropwithdrawreasondetails>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.1
</reportinggroupid>
<subjectsaffected>
3
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.2
</reportinggroupid>
<subjectsaffected>
9
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.3
</reportinggroupid>
<subjectsaffected>
7
</subjectsaffected>
</reasondetail>
</dropwithdrawreasondetails>
<reasontype>
Death
</reasontype>
</dropwithdrawreason>
<dropwithdrawreason>
<dropwithdrawreasondetails>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.1
</reportinggroupid>
<subjectsaffected>
3
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.2
</reportinggroupid>
<subjectsaffected>
1
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.3
</reportinggroupid>
<subjectsaffected>
3
</subjectsaffected>
</reasondetail>
</dropwithdrawreasondetails>
<reasontype>
Lack of Efficacy
</reasontype>
</dropwithdrawreason>
<dropwithdrawreason>
<dropwithdrawreasondetails>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.1
</reportinggroupid>
<subjectsaffected>
4
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.2
</reportinggroupid>
<subjectsaffected>
6
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.3
</reportinggroupid>
<subjectsaffected>
1
</subjectsaffected>
</reasondetail>
</dropwithdrawreasondetails>
<reasontype>
Lost to Follow-up
</reasontype>
</dropwithdrawreason>
<dropwithdrawreason>
<dropwithdrawreasondetails>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.1
</reportinggroupid>
<subjectsaffected>
2
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.2
</reportinggroupid>
<subjectsaffected>
2
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.3
</reportinggroupid>
<subjectsaffected>
3
</subjectsaffected>
</reasondetail>
</dropwithdrawreasondetails>
<reasontype>
Protocol Violation
</reasontype>
</dropwithdrawreason>
<dropwithdrawreason>
<dropwithdrawreasondetails>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.1
</reportinggroupid>
<subjectsaffected>
20
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.2
</reportinggroupid>
<subjectsaffected>
28
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.3
</reportinggroupid>
<subjectsaffected>
12
</subjectsaffected>
</reasondetail>
</dropwithdrawreasondetails>
<reasontype>
Withdrawal by Subject
</reasontype>
</dropwithdrawreason>
<dropwithdrawreason>
<dropwithdrawreasondetails>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.1
</reportinggroupid>
<subjectsaffected>
4
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.2
</reportinggroupid>
<subjectsaffected>
5
</subjectsaffected>
</reasondetail>
<reasondetail>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.3
</reportinggroupid>
<subjectsaffected>
3
</subjectsaffected>
</reasondetail>
</dropwithdrawreasondetails>
<otherreasonname>
Unclassified
</otherreasonname>
<reasontype>
Other
</reasontype>
</dropwithdrawreason>
</dropwithdrawreasons>
<milestones>
</milestones>
<otherparticipantflowdetails>
<otherdetail>
<numbernotcompleted>
45
</numbernotcompleted>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.1
</reportinggroupid>
</otherdetail>
<otherdetail>
<numbernotcompleted>
51
</numbernotcompleted>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.2
</reportinggroupid>
</otherdetail>
<otherdetail>
<numbernotcompleted>
34
</numbernotcompleted>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.3
</reportinggroupid>
</otherdetail>
</otherparticipantflowdetails>
<startedmilestone>
<milestoneachievements>
<milestoneachievement>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.1
</reportinggroupid>
<subjectsachieve>
234
</subjectsachieve>
</milestoneachievement>
<milestoneachievement>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.2
</reportinggroupid>
<subjectsachieve>
239
</subjectsachieve>
</milestoneachievement>
<milestoneachievement>
<reportinggroupid>
ParticipantFlow-ParticipantFlowGroup.3
</reportinggroupid>
<subjectsachieve>
235
</subjectsachieve>
</milestoneachievement>
</milestoneachievements>
</startedmilestone>
<title>
Overall Study
</title>
</period>
</periods>
<preassignmentdescription>
<textblock>
Eligible subjects continued their current oral anti-diabetic drug (OAD) treatment (metformin and/or sulphonylurea) without changing the dose throughout the trial. Subjects were asked not to alter their current diet and activities throughout the trial unless clinically necessary. Subjects fasted from 22:00 the evening prior to randomisation.
</textblock>
</preassignmentdescription>
<recruitmentdetails>
<textblock>
58 sites across the United Kingdom and Ireland.
Recruitment period: November 2004-August 2006
</textblock>
</recruitmentdetails>
</participantflow>
<pointofcontact>
<email>
clinicaltrials@novonordisk.com
</email>
<organizationname>
Novo Nordisk A/S
</organizationname>
<title>
Public Access to Clinical Trials
</title>
</pointofcontact>
<recordstatus>
RELEASED
</recordstatus>
<reportedevents>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<frequencyreportingthreshold>
5
</frequencyreportingthreshold>
<frequentadverseevents>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
33
</numevents>
<numsubjectsaffected>
14
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
24
</numevents>
<numsubjectsaffected>
16
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
40
</numevents>
<numsubjectsaffected>
27
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Abdominal discomfort
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
12
</numevents>
<numsubjectsaffected>
9
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
7
</numevents>
<numsubjectsaffected>
7
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
20
</numevents>
<numsubjectsaffected>
14
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Abdominal pain
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
19
</numevents>
<numsubjectsaffected>
19
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
14
</numevents>
<numsubjectsaffected>
13
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
16
</numevents>
<numsubjectsaffected>
14
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Blood and lymphatic system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Anaemia
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
16
</numevents>
<numsubjectsaffected>
15
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
32
</numevents>
<numsubjectsaffected>
23
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
32
</numevents>
<numsubjectsaffected>
25
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Arthralgia
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
40
</numevents>
<numsubjectsaffected>
31
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
42
</numevents>
<numsubjectsaffected>
38
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
35
</numevents>
<numsubjectsaffected>
28
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Back pain
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
17
</numevents>
<numsubjectsaffected>
12
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
13
</numevents>
<numsubjectsaffected>
10
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
17
</numevents>
<numsubjectsaffected>
6
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Bronchitis
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
66
</numevents>
<numsubjectsaffected>
48
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
63
</numevents>
<numsubjectsaffected>
51
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
46
</numevents>
<numsubjectsaffected>
38
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cough
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
10
</numevents>
<numsubjectsaffected>
8
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
12
</numevents>
<numsubjectsaffected>
12
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
16
</numevents>
<numsubjectsaffected>
16
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Psychiatric disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Depression
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
20
</numevents>
<numsubjectsaffected>
19
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
10
</numevents>
<numsubjectsaffected>
10
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
4
</numevents>
<numsubjectsaffected>
4
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Eye disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Diabetic retinopathy
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
115
</numevents>
<numsubjectsaffected>
60
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
75
</numevents>
<numsubjectsaffected>
53
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
63
</numevents>
<numsubjectsaffected>
45
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Diarrhoea
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
28
</numevents>
<numsubjectsaffected>
20
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
23
</numevents>
<numsubjectsaffected>
16
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
17
</numevents>
<numsubjectsaffected>
15
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Dizziness
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
38
</numevents>
<numsubjectsaffected>
21
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
15
</numevents>
<numsubjectsaffected>
14
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
19
</numevents>
<numsubjectsaffected>
13
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Dyspepsia
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
15
</numevents>
<numsubjectsaffected>
13
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
24
</numevents>
<numsubjectsaffected>
20
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
14
</numevents>
<numsubjectsaffected>
13
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Dyspnoea
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
8
</numevents>
<numsubjectsaffected>
6
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
15
</numevents>
<numsubjectsaffected>
11
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
17
</numevents>
<numsubjectsaffected>
17
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Ear infection
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
24
</numevents>
<numsubjectsaffected>
20
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
23
</numevents>
<numsubjectsaffected>
20
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
20
</numevents>
<numsubjectsaffected>
16
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Fall
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
15
</numevents>
<numsubjectsaffected>
12
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
12
</numevents>
<numsubjectsaffected>
10
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
7
</numevents>
<numsubjectsaffected>
4
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Fatigue
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
13
</numevents>
<numsubjectsaffected>
10
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
12
</numevents>
<numsubjectsaffected>
8
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
15
</numevents>
<numsubjectsaffected>
14
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Gastroenteritis
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
84
</numevents>
<numsubjectsaffected>
50
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
88
</numevents>
<numsubjectsaffected>
55
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
89
</numevents>
<numsubjectsaffected>
59
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Infection
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
55
</numevents>
<numsubjectsaffected>
37
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
33
</numevents>
<numsubjectsaffected>
29
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
43
</numevents>
<numsubjectsaffected>
33
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Influenza
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
49
</numevents>
<numsubjectsaffected>
39
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
50
</numevents>
<numsubjectsaffected>
34
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
46
</numevents>
<numsubjectsaffected>
34
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Injection site haematoma
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
23
</numevents>
<numsubjectsaffected>
18
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
7
</numevents>
<numsubjectsaffected>
7
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
21
</numevents>
<numsubjectsaffected>
16
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Injection site mass
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
15
</numevents>
<numsubjectsaffected>
14
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
14
</numevents>
<numsubjectsaffected>
14
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
8
</numevents>
<numsubjectsaffected>
8
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Joint swelling
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
13
</numevents>
<numsubjectsaffected>
9
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
14
</numevents>
<numsubjectsaffected>
12
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
20
</numevents>
<numsubjectsaffected>
16
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Localised infection
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
38
</numevents>
<numsubjectsaffected>
15
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
38
</numevents>
<numsubjectsaffected>
18
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
27
</numevents>
<numsubjectsaffected>
18
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Malaise
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
14
</numevents>
<numsubjectsaffected>
11
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
15
</numevents>
<numsubjectsaffected>
13
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
11
</numevents>
<numsubjectsaffected>
7
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Muscle spasms
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
251
</numevents>
<numsubjectsaffected>
108
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
211
</numevents>
<numsubjectsaffected>
97
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
208
</numevents>
<numsubjectsaffected>
99
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Nasopharyngitis
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
51
</numevents>
<numsubjectsaffected>
35
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
55
</numevents>
<numsubjectsaffected>
31
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
37
</numevents>
<numsubjectsaffected>
27
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Oropharyngeal pain
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
37
</numevents>
<numsubjectsaffected>
30
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
35
</numevents>
<numsubjectsaffected>
31
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
41
</numevents>
<numsubjectsaffected>
36
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pain in extremity
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
13
</numevents>
<numsubjectsaffected>
13
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
16
</numevents>
<numsubjectsaffected>
11
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
18
</numevents>
<numsubjectsaffected>
13
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Paraesthesia
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
17
</numevents>
<numsubjectsaffected>
13
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
8
</numevents>
<numsubjectsaffected>
8
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
9
</numevents>
<numsubjectsaffected>
7
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pharyngitis
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
14
</numevents>
<numsubjectsaffected>
11
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
12
</numevents>
<numsubjectsaffected>
12
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
14
</numevents>
<numsubjectsaffected>
14
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Skin and subcutaneous tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Rash
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
51
</numevents>
<numsubjectsaffected>
33
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
51
</numevents>
<numsubjectsaffected>
28
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
35
</numevents>
<numsubjectsaffected>
27
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Upper respiratory tract infection
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
67
</numevents>
<numsubjectsaffected>
32
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
31
</numevents>
<numsubjectsaffected>
24
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
60
</numevents>
<numsubjectsaffected>
30
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Urinary tract infection
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
12
</numevents>
<numsubjectsaffected>
12
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
13
</numevents>
<numsubjectsaffected>
10
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
17
</numevents>
<numsubjectsaffected>
13
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Viral infection
</term>
</frequentevent>
<frequentevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
80
</numevents>
<numsubjectsaffected>
45
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
68
</numevents>
<numsubjectsaffected>
44
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
71
</numevents>
<numsubjectsaffected>
43
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Vomiting
</term>
</frequentevent>
</frequentadverseevents>
<interventiongroups>
<interventiongroup
id="ReportedEvents-InterventionGroup.1"
>
<description>
<textblock>
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<numsubjectsfrequentevents>
227
</numsubjectsfrequentevents>
<numsubjectsseriousevents>
78
</numsubjectsseriousevents>
<partatriskfrequentevents>
234
</partatriskfrequentevents>
<partatriskseriousevents>
234
</partatriskseriousevents>
<title>
Insulin Detemir (Basal Insulin)
</title>
</interventiongroup>
<interventiongroup
id="ReportedEvents-InterventionGroup.2"
>
<description>
<textblock>
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
</textblock>
</description>
<numsubjectsfrequentevents>
235
</numsubjectsfrequentevents>
<numsubjectsseriousevents>
79
</numsubjectsseriousevents>
<partatriskfrequentevents>
239
</partatriskfrequentevents>
<partatriskseriousevents>
239
</partatriskseriousevents>
<title>
Insulin Aspart (Prandial Insulin)
</title>
</interventiongroup>
<interventiongroup
id="ReportedEvents-InterventionGroup.3"
>
<description>
<textblock>
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive
HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at
lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
</textblock>
</description>
<numsubjectsfrequentevents>
228
</numsubjectsfrequentevents>
<numsubjectsseriousevents>
105
</numsubjectsseriousevents>
<partatriskfrequentevents>
235
</partatriskfrequentevents>
<partatriskseriousevents>
235
</partatriskseriousevents>
<title>
Biphasic Insulin Aspart 30 (Biphasic Insulin)
</title>
</interventiongroup>
</interventiongroups>
<notes>
<textblock>
The safety analysis set contains all randomised subjects exposed to at least one dose of trial drug(s).
</textblock>
</notes>
<seriousadverseevents>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Abdominal abscess
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Abdominal distension
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
5
</numevents>
<numsubjectsaffected>
5
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Abdominal pain
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Abscess limb
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Accidental overdose
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Acute coronary syndrome
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Acute left ventricular failure
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Acute myocardial infarction
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Acute pulmonary oedema
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Adenocarcinoma pancreas
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Adverse drug reaction
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Hepatobiliary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Alcoholic liver disease
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Blood and lymphatic system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Anaemia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Anal abscess
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
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</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
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<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Anal fissure
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
5
</numevents>
<numsubjectsaffected>
4
</numsubjectsaffected>
<numsubjects>
234
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
4
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
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</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
11
</numevents>
<numsubjectsaffected>
8
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Angina pectoris
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Angina unstable
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Skin and subcutaneous tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Angioedema
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Ankle fracture
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Psychiatric disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Anxiety
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Psychiatric disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Anxiety disorder
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Aortic valve incompetence
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Aortic valve stenosis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Arterial stenosis limb
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Arteriosclerosis coronary artery
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Arthralgia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Arthritis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Ascites
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Asthenia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Asthma
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Atrial fibrillation
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Atrial flutter
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Atrioventricular block
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Atrioventricular block complete
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Atrioventricular block second degree
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
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1
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235
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Systematic Assessment
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<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Back injury
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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234
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239
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2
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2
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<numsubjects>
235
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<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Back pain
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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234
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ReportedEvents-InterventionGroup.2
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0
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239
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ReportedEvents-InterventionGroup.3
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0
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0
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235
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Basal cell carcinoma
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<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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234
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ReportedEvents-InterventionGroup.2
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1
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239
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ReportedEvents-InterventionGroup.3
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0
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235
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Basosquamous carcinoma
</term>
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<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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0
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0
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<numsubjects>
234
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ReportedEvents-InterventionGroup.2
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1
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1
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<numsubjects>
239
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<eventstats>
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ReportedEvents-InterventionGroup.3
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0
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0
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235
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<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Benign breast neoplasm
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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0
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0
</numsubjectsaffected>
<numsubjects>
234
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ReportedEvents-InterventionGroup.2
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0
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0
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239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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1
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<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
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<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Reproductive system and breast disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Benign prostatic hyperplasia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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0
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0
</numsubjectsaffected>
<numsubjects>
234
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ReportedEvents-InterventionGroup.2
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0
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0
</numsubjectsaffected>
<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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1
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<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
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<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Biliary sepsis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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0
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0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
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</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Investigations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Biopsy liver
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Bladder papilloma
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
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</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Bladder transitional cell carcinoma
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
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</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Borderline ovarian tumour
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Bradycardia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Brain contusion
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Bronchiectasis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Bronchitis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
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<eventstats>
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ReportedEvents-InterventionGroup.2
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<numevents>
0
</numevents>
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0
</numsubjectsaffected>
<numsubjects>
239
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</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Bronchpulmonary aspergillosis allergic
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Calculus ureteric
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
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</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Campylobacter gastroenteritis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cardiac arrest
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
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<eventstats>
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ReportedEvents-InterventionGroup.2
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5
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<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
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<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cardiac failure
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
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<eventstats>
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ReportedEvents-InterventionGroup.2
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0
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0
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239
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0
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0
</numsubjectsaffected>
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235
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<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cardiac failure acute
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
234
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ReportedEvents-InterventionGroup.2
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1
</numevents>
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1
</numsubjectsaffected>
<numsubjects>
239
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ReportedEvents-InterventionGroup.3
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5
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4
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235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cardiac failure congestive
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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0
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234
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0
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239
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1
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1
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<numsubjects>
235
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<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Carotid artery occlusion
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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0
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0
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234
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ReportedEvents-InterventionGroup.2
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0
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0
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239
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<eventstats>
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ReportedEvents-InterventionGroup.3
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1
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1
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<numsubjects>
235
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<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Carotid artery stenosis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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0
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0
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234
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ReportedEvents-InterventionGroup.2
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1
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1
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<numsubjects>
239
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<eventstats>
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ReportedEvents-InterventionGroup.3
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3
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<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Carpal tunnel syndrome
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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1
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<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
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ReportedEvents-InterventionGroup.2
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0
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0
</numsubjectsaffected>
<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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1
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<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Eye disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cataract
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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0
</numevents>
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0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Investigations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Catheterisation cardiac
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
6
</numevents>
<numsubjectsaffected>
6
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cellulitis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cellulitis orbital
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cerebral haemorrhage
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cerebral infarction
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cerebrovascular accident
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Change of bowel habit
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Chest discomfort
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Chest injury
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
5
</numevents>
<numsubjectsaffected>
5
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
6
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Chest pain
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Hepatobiliary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cholecystitis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Hepatobiliary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Cholelithiasis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Chronic obstructive pulmonary disease
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
4
</numevents>
<numsubjectsaffected>
4
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Circulatory collapse
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Clostridial infection
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
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</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Clostridium difficile colitis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
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Gastrointestinal disorders
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MedDRA Unspecified
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Coeliac disease
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Systematic Assessment
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</notes>
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Nervous system disorders
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MedDRA Unspecified
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Cognitive disorder
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Systematic Assessment
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</notes>
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Gastrointestinal disorders
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MedDRA Unspecified
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Colitis
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Systematic Assessment
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</notes>
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Gastrointestinal disorders
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MedDRA Unspecified
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Colitis ulcerative
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Systematic Assessment
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</notes>
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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MedDRA Unspecified
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<term>
Colon cancer
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Systematic Assessment
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</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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<sourcevocabulary>
MedDRA Unspecified
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<term>
Colon cancer stage I
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<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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234
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Systematic Assessment
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</notes>
<organsystemname>
Psychiatric disorders
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<sourcevocabulary>
MedDRA Unspecified
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<term>
Confusional state
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<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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235
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
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<sourcevocabulary>
MedDRA Unspecified
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<term>
Constipation
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<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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234
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2
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239
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235
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Cardiac disorders
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<sourcevocabulary>
MedDRA Unspecified
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<term>
Coronary artery disease
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<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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239
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Cardiac disorders
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<sourcevocabulary>
MedDRA Unspecified
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<term>
Coronary artery occlusion
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<seriousevent>
<adverseeventstats>
<eventstats>
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ReportedEvents-InterventionGroup.1
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239
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Cardiac disorders
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<sourcevocabulary>
MedDRA Unspecified
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<term>
Coronary artery stenosis
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<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
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<sourcevocabulary>
MedDRA Unspecified
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<term>
Crohn's disease
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<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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234
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1
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1
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239
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1
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235
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Deep vein thrombosis
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<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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1
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1
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234
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1
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1
</numsubjectsaffected>
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239
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235
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Metabolism and nutrition disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Dehydration
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<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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234
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239
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235
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Psychiatric disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Depression
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<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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234
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239
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235
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Systematic Assessment
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<notes>
</notes>
<organsystemname>
Metabolism and nutrition disorders
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<sourcevocabulary>
MedDRA Unspecified
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<term>
Diabetes mellitus inadequate control
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<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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239
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Eye disorders
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<sourcevocabulary>
MedDRA Unspecified
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<term>
Diabetic retinopathy
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<seriousevent>
<adverseeventstats>
<eventstats>
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234
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2
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239
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235
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Systematic Assessment
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<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
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<sourcevocabulary>
MedDRA Unspecified
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<term>
Diarrhoea
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<seriousevent>
<adverseeventstats>
<eventstats>
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ReportedEvents-InterventionGroup.1
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234
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Systematic Assessment
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</notes>
<organsystemname>
General disorders
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MedDRA Unspecified
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<term>
Dislocation of joint prosthesis
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<seriousevent>
<adverseeventstats>
<eventstats>
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Systematic Assessment
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</notes>
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Infections and infestations
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MedDRA Unspecified
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<term>
Diverticulitis
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<seriousevent>
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<eventstats>
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239
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Systematic Assessment
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<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
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<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Diverticulum
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<seriousevent>
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<eventstats>
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239
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<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Dizziness
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Drug dispensing error
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Duodenal ulcer
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Dupuytren's contracture operation
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Dyspepsia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Dysphonia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Dyspnoea
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Dysuria
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Endometrial cancer
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Endometrial cancer stage III
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Epigastric discomfort
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Epistaxis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Eye disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Eyelid ptosis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Faeces discoloured
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Fall
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Femoral arterial stenosis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Femoral artery occlusion
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Femoral neck fracture
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Metabolism and nutrition disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Fluid retention
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Food poisoning
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Foot deformity
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Gait disturbance
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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1
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1
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234
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ReportedEvents-InterventionGroup.2
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0
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0
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239
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<eventstats>
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ReportedEvents-InterventionGroup.3
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0
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0
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235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Galbladder cancer
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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0
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0
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<numsubjects>
234
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ReportedEvents-InterventionGroup.2
</reportinggroupid>
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1
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1
</numsubjectsaffected>
<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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0
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0
</numsubjectsaffected>
<numsubjects>
235
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</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Gangrene
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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<numevents>
0
</numevents>
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0
</numsubjectsaffected>
<numsubjects>
239
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</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Gastric ulcer
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Gastritis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
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</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Gastritis haemorrhagic
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
4
</numevents>
<numsubjectsaffected>
4
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Gastroenteritis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Gastrointestinal haemorrhage
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Gastrooesophageal reflux disease
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Endocrine disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Goitre
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Graft infection
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Groin pain
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Haemarthrosis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Haematemesis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Haematochezia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Haematoma
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Reproductive system and breast disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Haematospermia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Haematuria
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Head injury
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Hepatic neoplasm malignant recurrent
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Hip fracture
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
7
</numevents>
<numsubjectsaffected>
5
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
13
</numevents>
<numsubjectsaffected>
13
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
14
</numevents>
<numsubjectsaffected>
12
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Metabolism and nutrition disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Hypoglycaemia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Hypoglycaemic coma
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Metabolism and nutrition disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Hypoglycaemic unconsciousness
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Hypotension
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Incisional hernia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Infected skin ulcer
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Infective exacerbation of chronic obstructive airways
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Skin and subcutaneous tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Ingrowing nail
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Inguinal hernia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Intentional overdose
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Intermittent claudication
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Investigations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
International normalised ratio increased
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Intervertebral disc compression
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Intervertebral disc protrusion
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Intestinal ischaemia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Intestinal obstruction
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
4
</numevents>
<numsubjectsaffected>
4
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Blood and lymphatic system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Iron deficiency anaemia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Ischaemia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Joint injury
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Joint sprain
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Surgical and medical procedures
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Knee arthroplasty
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Labyrinthitis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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234
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239
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1
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<numsubjects>
235
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<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Lacunar infarction
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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234
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ReportedEvents-InterventionGroup.2
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1
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1
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<numsubjects>
239
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<eventstats>
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ReportedEvents-InterventionGroup.3
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0
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0
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<numsubjects>
235
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<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Laryngeal cancer
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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0
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0
</numsubjectsaffected>
<numsubjects>
234
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ReportedEvents-InterventionGroup.2
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0
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0
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<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
1
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1
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Left ventribular dysfunction
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
234
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ReportedEvents-InterventionGroup.2
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<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Left ventricular failure
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
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<eventstats>
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ReportedEvents-InterventionGroup.2
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Leiomyosarcoma metastatic
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
4
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Skin and subcutaneous tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Lichen sclerosus
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Ligament rupture
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Lobar pneumonia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Localised infection
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Loss of consciousness
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Lower extremity mass
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Lower respiratory tract infection
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Lung neoplasm malignant
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Medication error
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Melaena
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Meniscus lesion
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Metastases to liver
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Metastases to lung
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Metastatic neoplasm
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Multi-organ failure
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Muscle haemorrhage
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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0
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0
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234
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0
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0
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<numsubjects>
239
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<eventstats>
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ReportedEvents-InterventionGroup.3
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2
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<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Muscular weakness
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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1
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1
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<numsubjects>
234
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ReportedEvents-InterventionGroup.2
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<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
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<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Musculoskeletal chest pain
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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1
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1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
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<eventstats>
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ReportedEvents-InterventionGroup.2
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0
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<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
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</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Musculoskeletal pain
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
6
</numevents>
<numsubjectsaffected>
6
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
4
</numevents>
<numsubjectsaffected>
4
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Myocardial infarction
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
4
</numevents>
<numsubjectsaffected>
4
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Myocardial ischaemia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Nail infection
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Nausea
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Nephrolithiasis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Neuropathic arthropathy
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Neuropathy peripheral
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Non-cardiac chest pain
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Non-small cell lung cancer metastatic
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Non-small cell lung cancer stage IIIB
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Oedema peripheral
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Oesophageal food impaction
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Oesophageal rupture
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Oesophageal spasm
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Oesophageal ulcer
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Oesophagitis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Eye disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Optic ischaemic neuropathy
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
4
</numevents>
<numsubjectsaffected>
4
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
7
</numevents>
<numsubjectsaffected>
6
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Osteoarthritis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
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<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
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0
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<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Osteoporosis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Reproductive system and breast disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Ovarian cyst
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pain in extremity
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Palpitations
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pancreatic carcinoma
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pancreatic pseudocyst
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pancreatitis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pancreatitis chronic
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pancreatolithiasis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Psychiatric disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Panic attack
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Paraesthesia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Surgical and medical procedures
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Penile prosthesis insertion
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Peptic ulcer
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Periarthritis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Perineal abscess
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Peripheral vascular disorder
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Blood and lymphatic system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pernicious anaemia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pilonidal cyst
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pleural effusion
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pneumocephalus
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pneumonia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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0
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0
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<numsubjects>
234
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<eventstats>
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ReportedEvents-InterventionGroup.2
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0
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0
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<numsubjects>
239
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<eventstats>
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ReportedEvents-InterventionGroup.3
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1
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1
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<numsubjects>
235
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<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Polymyalgia rheumatica
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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0
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0
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<numsubjects>
234
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ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
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</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Post procedural complication
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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0
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<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Postoperative wound infection
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Presyncope
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Prostate cancer
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Reproductive system and breast disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Prostatomegaly
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Skin and subcutaneous tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pruritis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pulmonary embolism
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pulmonary oedema
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Investigations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pulse absent
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pyelonephritis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
General disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Pyrexia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Radiculitis brachial
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Radius fracture
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Rectal cancer metastatic
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Rectal cancer stage III
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Rectal haemorrhage
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Renal colic
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Renal failure
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Renal failure acute
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Renal failure chronic
</term>
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<seriousevent>
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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1
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1
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234
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1
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239
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2
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235
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<assessmenttype>
Systematic Assessment
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<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Renal impairment
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
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234
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0
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0
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<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Respiratory failure
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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1
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1
</numsubjectsaffected>
<numsubjects>
234
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ReportedEvents-InterventionGroup.2
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0
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0
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<numsubjects>
239
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<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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0
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<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
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</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Respiratory tract infection
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
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0
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0
</numsubjectsaffected>
<numsubjects>
234
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<eventstats>
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ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
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<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Eye disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Retinal detachment
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Rheumatoid arthritis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Right ventricular failure
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Scrotal abscess
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Sensory loss
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Sepsis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Sinus bradycardia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Skin and subcutaneous tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Skin ulcer
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Skull fracture base
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Sleep apnoea syndrome
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Small intestinal haemorrhage
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Investigations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Smear cervix abnormal
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Spinal cord compression
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Staphylococcal osteomyelitis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Stent related infection
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Subarachnoid haemorrhage
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
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</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Subdural haemorrhage
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Musculoskeletal and connective tissue disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Synovitis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Tibia fracture
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Nervous system disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Transient ischaemic attack
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Transitional cell carcinoma
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Cardiac disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Tricuspid valve incompetence
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Umbilical hernia
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Surgical and medical procedures
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Umbilical hernia repair
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Upper respiratory tract infection
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Urethral meatus stenosis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Urethral stenosis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Renal and urinary disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Urinary retention
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
3
</numevents>
<numsubjectsaffected>
3
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Urinary tract infection
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Reproductive system and breast disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Vaginal haemorrhage
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Varicose vein
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Vascular disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Vasculitis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Eye disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Vision blurred
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Gastrointestinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Vomiting
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Respiratory, thoracic and mediastinal disorders
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Wegener's granulomatosis
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Infections and infestations
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Wound infection
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Wrist fracture
</term>
</seriousevent>
<seriousevent>
<adverseeventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.1
</reportinggroupid>
<numevents>
2
</numevents>
<numsubjectsaffected>
2
</numsubjectsaffected>
<numsubjects>
234
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.2
</reportinggroupid>
<numevents>
1
</numevents>
<numsubjectsaffected>
1
</numsubjectsaffected>
<numsubjects>
239
</numsubjects>
</eventstats>
<eventstats>
<reportinggroupid>
ReportedEvents-InterventionGroup.3
</reportinggroupid>
<numevents>
0
</numevents>
<numsubjectsaffected>
0
</numsubjectsaffected>
<numsubjects>
235
</numsubjects>
</eventstats>
</adverseeventstats>
<assessmenttype>
Systematic Assessment
</assessmenttype>
<notes>
</notes>
<organsystemname>
Injury, poisoning and procedural complications
</organsystemname>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<term>
Wrong drug administered
</term>
</seriousevent>
</seriousadverseevents>
<sourcevocabulary>
MedDRA Unspecified
</sourcevocabulary>
<timeframe>
The adverse events were collected from the first trial-related activity once the subject had signed the informed consent, up until 28 days after the last clinic visit. Total reporting period for adverse events was 162 weeks.
</timeframe>
</reportedevents>
</clinical_result>
